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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K042881
Device Name PMD-2000 INTERFERENTIAL STIMULATOR
Applicant
Phoenix Medical Devices, LLC
620 Newport Center
Suite 1100
Newport Beach,  CA  92660
Applicant Contact JIM KLETT
Correspondent
Entela, Inc.
3033 Madison Ave., SE
Grand Rapids,  MI  49548
Correspondent Contact NEIL E DEVINE
Regulation Number890.5850
Classification Product Code
IPF  
Date Received10/19/2004
Decision Date 11/18/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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